FDA 510(k) clearances — page 509
clearances on record, most recent first.
Clearances — page 509
50,801–50,900 of 176,542- K093707 — DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
- K100403 — MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
- K100409 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
- K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
- K100652 — ACL TIGHTROPE
- K100773 — KAI SPOT MODEL KMS 200
- K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
- K101063 — SLEEVE WITH ZIPLOOP FIXATION DEVICES
- K101116 — HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
- K101217 — MAC-MOBILE AQUATIC CHAIR
- K101227 — BACK-TEK
- K101228 — MIRADA XD
- K101481 — BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
- K101492 — 8 CHANNEL CARDIAC PHASED ARRAY COIL
- K101546 — ENDOFORM DENTAL TEMPLATE
- K090081 — TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS
- K092874 — POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
- K093108 — STRYKER BIPOLAR FORCEPS
- K093407 — ZQUIET MOUTHPIECE
- K093955 — ANTI-HAV IGM
- K100388 — 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
- K100495 — PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
- K100538 — TINA-QUANT FERRITIN GEN. 4
- K100631 — AFFIITY CP CENTRIFUGAL BLOOD PUMP
- K100908 — UNICEM HM
- K101074 — MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
- K101137 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE
- K101138 — SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
- K101345 — WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
- K101385 — DUAL LUER LOCK CAP, MODEL 2C6250
- K101430 — MLS-AC DERMA SCANNER
- K101451 — APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
- K101564 — CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
- K100333 — FIAB SPA, MODELS F7244, F7233, F7234, F7277
- K100497 — QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
- K100781 — OBSIDIAN CERAMIC BLOCKS
- K101080 — NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX
- K101448 — OPUS SPEEDSCREW SYSTEM
- K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
- K092052 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
- K092938 — HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
- K093109 — NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
- K093320 — DRYODINE CADEXOMER-IODINE GEL
- K093335 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
- K093376 — LASSO NAV CATHETER
- K093566 — CARTO XP EP NAVIGATION SYSTEM, VERSION 10
- K093623 — GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
- K093810 — BF-NAVI
- K100501 — MULTIFUNCTIONAL LINEAR PEN
- K100638 — VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214
- K100685 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K100801 — PUMA MODEL VERSION 1.0
- K100900 — MOTIVATION KNEE SYSTEM
- K101111 — HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
- K101115 — ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
- K101440 — GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
- K101449 — INTELLIVUE PATIENT MONITOR
- K101475 — COMPRESS ANTI-ROTATION SPINDLES
- K092564 — O-ARM IMAGING SYSTEM
- K093395 — OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
- K093466 — HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
- K093619 — EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
- K100425 — HASKAL TORQUE DEVICE
- K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
- K100861 — R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
- K100896 — GYRUS ACMI HALO PKS CUTTING FORCEPS
- K101017 — ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
- K101131 — FIDUCIAL MARKERS
- K101218 — PATCHASSIST
- K101259 — V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
- K101362 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K101399 — COAXIAL INTRODUCER SET
- K101438 — T2 GREATER TROCHANTER NAIL
- K101523 — CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
- K091928 — 10 X 10 VISION
- K092194 — POLYBONE DENTAL
- K093351 — COLLAWOUND ART
- K093800 — ROBINSON MEDSURG QUICKSCREW RACK
- K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001
- K100043 — COROENT XLR STANDALONE SYSTEM
- K100176 — ASCENSION ANKLE FUSION PLATE SYSTEM
- K100815 — OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
- K100836 — CLEARPOINT SYSTEM
- K100893 — CHEVEUX DIODE LASER SYSTEM
- K100929 — UNIMOM ALLEGRO
- K101119 — SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
- K101406 — ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
- K092107 — VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
- K092638 — FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
- K093951 — OUCHLESS MODEL PN10114
- K101421 — MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
- K082102 — GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
- K090608 — MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
- K094009 — HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI
- K100099 — ORAL/ENTERAL SYRINGES
- K100233 — SUDOSCAN
- K100366 — MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
- K100604 — OTIS -C PLUS
- K100800 — TIDI FACEMASK
- K100981 — UNITED STEM, PSA TYPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.